Device product
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Z-0411-2026
Product summary
- Event
- Event 97470
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8
- Official record key
device-enforcement:Z-0411-2026
Official wording
Reason: An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
Code information: UDI:00844685014316. Lots: 207552 and 208238
Distribution pattern: US Nationwide distribution in the state of GA.
Derived failure modes
-
Unknown
An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation